Senior Regulatory Affairs Specialist - Vascular

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

·  Career development with an international company where you can grow the career you dream of
·  Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
·  An excellent retirement savings plan with high employer contribution
·  Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
·  A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
·  A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Santa Clara, CA, currently has an opportunity for a Senior Regulatory Affairs Specialist . As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions.  This new team member may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.  The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

WHAT YOU’LL DO

Strategic Planning:

·  Assist in SOP development and review.
·  Provide regulatory input to product lifecycle planning.
·  Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
·  Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
·  Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
·  Determine trade issues to anticipate regulatory obstacles.
·  Determine and communicate submission and approval requirements.
·  Participate in risk-benefit analysis for regulatory compliance.

Premarket:

·  Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
·  Compile, prepare, review and submit regulatory submission to authorities.
·  Monitor impact of changing regulations on submission strategies.
·  Monitor applications under regulatory review.
·  Monitor and submit applicable reports to regulatory authorities.
·  Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
·  Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Postmarket:

·  Maintain annual licenses, registrations, listings and patent information.
·  Assist compliance with product postmarketing approval requirements.
·  Review and approve advertising and promotional items to ensure regulatory compliance.
·  Assess external communications relative to regulations.
·  Review regulatory aspects of contracts.
·  Assist with label development and review for compliance before release.
·  Submit and review change controls to determine the level of change and consequent submission requirements.
·  Analyze the input of cumulative product changes to current product submissions.
·  Contribute to the development and functioning of the crisis/ issue management program.
·  Ensure product safety issues and product-associated events are reported to regulatory agencies.
·  Provide regulatory input for product recalls and recall communications.

Required Qualifications

·  Bachelor's Degree in a related field OR an equivalent combination of education and work experience
·  3-4 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
·  2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
·  Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
·  Ability to work effectively on cross-functional teams.
·  Pay strong attention to detail.
·  Organize and track complex information.
·  Exercise good and ethical judgment within policy and regulations
·  Use in-depth knowledge of business functions and cross group dependencies/ relationships.
·  Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Preferred Qualifications

·  Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields
·  Master’s in Regulatory Affairs or technical area; M.B.A. A Ph.D. or law is helpful.
·  Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
·  Previous experience with 510k / PMA and EU MDR submissions
·  Experience with Medical Devices
·  Must be able to juggle multiple and competing priorities
·  Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
·  Has a sound knowledge of a variety of alternatives and their impact on the business

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is
$83,600.00 – $167,200.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Santa Clara : Building B - SC

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf